HIV Infections
Conditions
Keywords
Nausea, Vomiting, Retching, HIV/AIDS, Symptom Management, Complementary Therapies
Brief summary
The subjects in this research study will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of two hours or more (per day) in baseline symptom diaries. Subjects will be randomized (by chance) to one of three conditions: Condition 1, subjects receive Standard acupuncture (active treatment); Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis (active treatment); Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in Conditions 1, 2, & 3 will attend scheduled sessions over 24 weeks.
Detailed description
The subjects in the proposed experiment will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in prospective baseline symptom diaries. Subjects will be randomized to one of three experimental intervention conditions: Condition 1, subjects receive Standard acupuncture; Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis; Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in Conditions 1, 2, & 3 will attend 16 scheduled sessions over 24 weeks. All subjects will: be assessed by a diagnostic acupuncturist (blinded to treatment assignments); be administered the same instruments; and submit their symptom diaries for data entry and analysis. After a screening/intake session, randomization and treatment sessions will follow. There will be four weeks of twice weekly treatment sessions, four weekly treatment sessions and three follow-up sessions. All conditions will be identical in duration and be administered by licensed acupuncturists trained in Traditional Chinese Medicine. This study is a prospective, randomized, controlled, blinded (subject and evaluator), parallel groups clinical trial aimed at reducing chronic nausea and improving quality of life in persons with HIV/AIDS.
Interventions
OTHERAcupuncture
Standard Acup point protocol for treating nausea
OTHERIndividualized Acup based on TCM diagnosis
Acup
OTHERSham Acup
Sham Acup - Non-Active
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men and women HIV positive or CDC AIDS diagnosed * History of chronic nausea for three months or greater * Experience an average of two or more episodes of nausea and/or who experience an average duration of 2 hours or more (of nausea) per day * Verification from Primary provider of subject's: HIV status, knowledge of patient's nausea and their agreement that their patient is clinically suitable for the study. * Individuals able to successfully complete a mini-mental status exam * Individuals who understand and agree to complete daily symptom diaries for the duration of the study. * Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug(s), dose & frequency) prior to entry into the study. * Individuals taking anti-emetic medications must be on a stable regime (same drug, dose & frequency) for at least fourteen days prior to entry into the study. * Individuals on all other medications which may have nausea listed as a side effect must be on a stable regime (same drug(s), dose & frequency) for at least fourteen (14) days prior to entry in the study
Exclusion criteria
* Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis and or other opportunistic infections or conditions that would require medical attention. * Pregnant women * Individuals receiving acupuncture currently and less than 6 months prior to enrollment. * Individuals currently receiving other types of complementary therapies such as herbs, massage, acupressure wrist bands, reiki etc. * Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INVR - symptom diary Clinical Global Impression Scales | Baseline, treatment and follow-ups sessions |
Secondary
| Measure | Time frame |
|---|---|
| QOL scale MOS-SF-36 subscales | Baseline, treatment and follow-up session |
Outcome results
None listed